Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ARTELAC
Active substances:
Estonian, English, Latin
ATC code: S01XA82
Dosage form: eye drops, solution
Strength: 3,2mg 1ml
Legal status for supply*: Not subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated October 18, 2023)
Package information leaflet (PIL): EST  (last updated October 18, 2023)
Translation of package information leaflet into Russian: RUS  (last updated January 13, 2021)
Translation of package information leaflet into English: ENG  (last updated January 13, 2021)
Labelling:  (last updated October 18, 2023)
Indication: Symptomatic treatment of dessication of the cornea and conjunctiva which are caused by disturbed tear secretion due to local or systemic diseases and/or change in the composition of tear fluid, deficient eyelid or incomplete eyelid closure.
Marketing authorization holder: Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH 
Marketing authorization number: 269099 
Marketing authorization issued on: June 14, 1999 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: National 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1038136  ARTELAC  eye drops, solution  3,2mg 1ml 10ml 1TK  OTC      12.06.2024     
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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